Comments for MEDB 5510, Week 01

Topics to be covered

  • What you will learn
    • Defining Clinical Research Methodology
    • Quantitative versus qualitative research
    • Other research dichotomies

Learning objectives

  • To describe the variety of research that can be conducted while doing clinical research.

  • To describe what is needed in order to identify and define a research question that could be the basis for a research project.

What is research?

  • ” systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”

  • “Disciplined method” or “disciplined inquiry”

What is clinical? What is methodology?

  • Clinical: “concerned with or based on actual observation and treatment of disease in patients rather than experimentation or theory.”

  • Methodology: “a body of methods, rules, and postulates employed by a discipline : a particular procedure or set of procedures”

Research “flavors”

  • Many different nouns, same basic concept
    • Research aim
    • Research approach
    • Research goal
    • Research hypothesis
    • Research question
    • Research topic

Elements of a research hypothesis

  • PICO
    • P = patient population
    • I = intervention (or exposure)
    • C = control or comparison group
    • O = outcome
  • PICOTS
    • T = time frame
    • S = setting

Where do research ideas come from?

Ronan Conroy has an excellent summary.

  • Exploring your environment.

  • Don’t focus prematurely on a single idea.

  • Extending the ideas of others.

  • Getting a research idea by reading papers.

My theory

  • Irritation

Uses of clinical research

  • Practical application.

  • Theory development.

  • Development of research tools.

  • Professional development.

Break #1

  • What you have learned
    • Defining Clinical Research Methodology
  • What’s coming next
    • Quantitative versus qualitative research

Quantitative research versus qualitative research

Quantitative research.

  • Synonym(?): Positivistic.

  • Highly structured, A priori specifications.

  • Separates the researcher from the research.

  • Data is easily represented as numbers

Quantitative research versus qualitative research

  • Qualitative research.

    • Synonyms(?): Constructivist, humanist.

    • Covers five sub-areas: phenomological, grounded theory, ethnographic, case study, and narrative research.

    • Open ended questions. Research guides and is guided by the research process.

    • Data is open ended text–difficult to represent as numbers

    • Measures perceptions, feelings, values

  • Postpositivism tries to reconcile quantitative and qualitative approaches.

Quote in support of quantitative data

  • “When you can measure what you are speaking about, and express it in numbers, you know something about it, when you cannot express it in numbers, your knowledge is of a meager and unsatisfactory kind; it may be the beginning of knowledge, but you have scarely, in your thoughts advanced to the stage of science.”

Quote critical of quantitative data

  • “The individual source of the statistics may easily be the weakest link. Harold Cox tells a story of his life as a young man in India. He quoted some statistics to a Judge, an Englishman, and a very good fellow. His friend said, Cox, when you are a bit older, you will not quote Indian statistics with that assurance.”

Quote critical of quantitative data

  • “The Government are very keen on amassing statistics—they collect them, add them, raise them to the nth power, take the cube root and prepare wonderful diagrams. But what you must never forget is that every one of those figures comes in the first instance from the chowty dar [chowkidar] (village watchman), who just puts down what he damn pleases.”

Break #2

  • What you have learned
    • Quantitative versus qualitative research
  • What’s coming next
    • Other research dichotomies

Research dichotomies

  • Dichotomies are always wrong.
    • Trichotomies.
    • Monochotomies.
    • Spectrum.
  • But they are still useful.
    • Shorthand for others.
    • Guidance for statistical analysis.
    • Helpful for critical appraisal.
  • No “best” level in these dichotomies.
  • Mixed methods.

Theoretical versus applied

  • Theoretical: no benefit to patients now.
  • Applied: potential for immediate benefit.
  • “Experience by itself teaches nothing… Without theory, experience has no meaning. Without theory, one has no questions to ask. Hence, without theory, there is no learning.”
    • W. Edwards Deming, in The New Economics for Industry, Government, Education.

Translational versus basic

  • Basic research: “without thought of practical ends.”
    • .
  • Translational research: transition from “bench to bedside.”
    • Called T1 research.
    • Next step (T2): transition from bedside to community.
    • T3, T4, T5???

Laboratory versus field.

  • Laboratory: controlled setting

    • Unnatural.

    • Control extraneous variables.

  • Field setting: in the clinic

  • Ecologic validity: “the methods, materials and setting of the study must approximate the real-world that is being examined.”

Experimental versus observational

  • Experimental
    • Researcher chooses the intervention
    • Allows for randomization
  • Observational
    • Patient/doctor chooses the intervention
    • Groups not under anyone’s control

Participant report versus researcher observation

  • Participant report.
    • Either written or oral.
    • Only practical approach for pain, quality of life.
    • Also known as Patient Reported Outcomes (PRO).
  • Researcher observation.
    • Also includes instruments like a heart rate monitor.
    • Perceived as more objective.

Summary

  • What you have learned
    • Defining Clinical Research Methodology
    • Quantitative versus qualitative research
    • Other research dichotomies